Call for Submissions Proposal P1044

1 March 2018

[40–18]

Call for submissions – Proposal P1044

Plain English Allergen Labelling (PEAL)

FSANZ has assessed a proposal for requiring mandatory food allergen declarations to be made clearer and in plain English. Pursuant to section 72 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), FSANZ now calls for submissions to assist further consideration of the proposal.

For information about making a submission, visit the FSANZ website at information for submitters.

All submissions on applications and proposals will be published on our website. We will not publish material that we accept as confidential, but will record that such information is held. In-confidence submissions may be subject to release under the provisions of the Freedom of Information Act 1991. Submissions will be published as soon as possible after the end of the public comment period. Where large numbers of documents are involved, FSANZ will make these available on CD, rather than on the website.

Under section 114 of the FSANZ Act, some information provided to FSANZ cannot be disclosed. More information about the disclosure of confidential commercial information is available on the FSANZ website at information for submitters.

Submissions should be made in writing; be marked clearly with the word ‘Submission’ and quote the correct project number and name. While FSANZ accepts submissions in hard copy to our offices, it is more convenient and quicker to receive submissions electronically through the FSANZ website via the link on documents for public comment. You can also email your submission directly to .

There is no need to send a hard copy of your submission if you have submitted it by email or via the FSANZ website. FSANZ endeavours to formally acknowledge receipt of submissions within 3 business days.

DEADLINE FOR SUBMISSIONS: 6pm (Canberra time) 12 April 2018

Submissions received after this date will not be considered unless an extension had been given before the closing date. Extensions will only be granted due to extraordinary circumstances during the submission period. Any agreed extension will be notified on the FSANZ website and will apply to all submitters.

Questions about making submissions or the application process can be sent to .

Hard copy submissions may be sent to one of the following addresses:

Food Standards Australia New ZealandFood Standards Australia New Zealand

PO Box 5423PO Box 10559

KINGSTON ACT 2604The Terrace WELLINGTON 6143

AUSTRALIANEW ZEALAND

Tel +61 2 6271 2222 Tel +64 4 978 5630

Table of contents

Executive summary

1Introduction

1.1Reasons for preparing this proposal

1.2Scope

1.3Procedure for assessment

1.4Risk assessment

2Background

2.1The current standards

2.2Voluntary food industry guidelines

2.3International and overseas regulations

3Issues

3.1Clarifying terminology for fish, crustacea and mollusc declarations

3.2Clarifying terminology for tree nut declarations

3.3Terminology issues for the declaration of wheat and cereals containing gluten

3.4Potential approaches for introducing PEAL

3.5Placement of allergen declarations on food labels

4Matters addressed in accordance with the FSANZ Act

4.1Section 59 – Costs and benefits identified at the first call for submissions

4.2Section 59 – Any relevant New Zealand standards

4.3Section 59 – Other relevant matters

4.3.1Section 18 – FSANZ’s objectives in developing, reviewing and varying standards

5Risk communication

5.1Consultation

5.2World Trade Organization (WTO)

6List of questions for submitters

7References

Supporting documents

The following documents[1] informed the assessment of this proposal and are available on the FSANZ website:

SD1Safety Risk Assessment

SD2Consumer understanding, attitudes and behaviour in relation to food allergen labelling

Executive summary

Standard 1.2.3 – Information requirements – warning statements, advisory statements and declarations of the Australia New Zealand Food Standards Code (the Code) requires the mandatory declaration of the presence of certain substances in food which can cause severe allergic and other reactions (referred to collectively in this paper as allergens). However, the Standard does not mandate how these declarations should be made or what terminology should be used.

FSANZ has previously identified a lack of clarity in the Code on how to declare certain allergens, which is resulting in the use of unclear terminology when these allergens are declared. These issues relate to:

fish, crustacea and molluscs
tree nuts
cereals containing gluten.

From previous stakeholder consultations and a qualitative survey of New Zealand food labels, FSANZ has also identified other issues that may sometimes arise with allergen declarations.

The lack of clarity in the allergen declaration requirementsin the Code mean food allergen sensitive consumers (or those who purchase foods for these consumers) may not always be able to use allergen declaration information to make informed food choices. This in turn creates risks for the health and safety of these consumers.

The purpose of this proposal is to consider variations to the Code that may be necessary to address the above risks to food allergen sensitive consumers. In particular, FSANZ is considering variations to the Code to provide clarity in allergen declaration requirements, and to require the use of plain English allergen labelling (PEAL) as a means of improving allergen information for consumers. PEAL is considered to be the use of clear and unambiguous terms in allergen declarations, primarily by reference to the specific source for the allergen.

For this proposal FSANZ has to date undertaken two assessment activities to explore issues associated with PEAL, consisting of:

an assessment of safety issues relating to food allergy associated with fish, crustacea and molluscs; tree nuts; and cereals (see Supporting Document 1) including seeking advice from FSANZ’s Food Allergy and Intolerance Scientific Advisory Group (FAISAG).
a preliminary assessment of consumer understanding, attitudes and behaviour in relation to food allergen labelling (see Supporting Document 2).

FSANZ’s preliminary view, based on the available evidence, is that:

the status quo (Option 1) appears not to be an option that would address the risks to food allergen sensitive consumers mentioned above; and
varying the Code (Option 2) appears warranted to clarify allergen declaration requirements for fish, crustacea, molluscs, tree nuts and cereals containing gluten, and to address other issues with the terminology used to declare allergens more generally.

The particular manner or form of any such variations to the Code has yet to be decided. Potential approaches for varying the Code are outlined throughout this report.

This proposal is being assessed under the Major Procedure requirements of the FSANZ Act, which require two rounds of public consultation. This is the first round of public consultation. Submitters are therefore invited to provide comment on the issues raised and potential approaches discussed. To facilitate submitter comment, a series of questions are located after each relevant section in the report, and are listed together at Section 6 of this report.

Information received in response to this consultation will inform any proposed draft variation of the Code, which wouldthen be provided for comment at the next round of public consultation.

1Introduction

1.1Reasons for preparing this proposal

In two previous reviews, FSANZ identified issues that can lead to unclear allergen declarations. The first review W3 – Review of the regulatory management of food allergens (the W3 Review) (FSANZ, 2010) was completed in 2010, and identified potential issues specifically with the requirements to declare fish, crustacea and molluscs; tree nuts; and cereals containing gluten.

FSANZ conducted a further review W1070 – Plain English Allergen Labelling (W1070 review) in 2015 to explore how terminology was being used to declare allergens on Australian and New Zealand foods. This review included a qualitative survey of New Zealand food labels and targeted consultation (FSANZ, 2016). The review found issues with allergen declarations being either too vague (e.g. ‘gluten containing cereals’ rather than ‘wheat’), inaccurate (e.g. ‘fish’ for foods containing molluscs), or too technical (e.g. ‘sodium caseinate’ without an indication it is from a dairy source). The W1070 Review concluded there is no consistency in how allergens are declared, due to variability in the terminology used across different foods (in the statement of ingredients and in the ‘contains’ statement) making identification of allergenic ingredients difficult. The W1070 Review also identified variability in the use of the ‘contains’ statement given it is voluntary, and difficulty in relating terminology used in the ‘contains’ statement to ingredient names.

The lack of clarity relating to allergen declarationsunder Code provisions means food allergen sensitive consumers (or those who purchase foods for these consumers) may not always be able to use allergen declaration information to make informed and safe food choices. This creates risks for the health and safety of these consumers, as well as making it harder for allergen sensitive consumers to find allergen information, and potentially a loss of confidence in allergen declarations in general.

Therefore, the purpose of this proposal is to consider variations to the Code that may be necessary to address the above risks to food allergen sensitive consumers. In particular, FSANZ is considering variations to the Code to provide clarity in allergen declaration requirements, and to require the use of plain English allergen labelling (PEAL) as a means of improving allergen information for consumers. PEAL is considered to be the use of clear and unambiguous terms in allergen declarations, primarily by reference to the specific source of the allergen.

1.2Scope

Proposal P1044 will consider changes to the Code to address identified issues with the clarity of the existing allergen declaration requirements. It will also consider whether changes to the Code are required to ensure allergen declarations are made clearly and in plain English. The scope includes allergen declarations for both packaged food and food not required to bear a label, although FSANZ acknowledges there may be fewer issues associated with the latter (see Section 2.1.2 about food not required to bear a label).

The following matters are out of the scope:

Consideration of new allergens requiring mandatory declaration in the Code.
Formatting issues. For example, the emboldening of allergen declarations, which the Australia New Zealand Ministerial Forum on Food Regulation (the Forum) has considered in response to recommendation 47[2] of Labelling Logic: Review of food labelling law and policy (Blewett et al. 2011). In 2016, the Forum agreed no further action was required on this recommendation.
Issues relating to the unintended presence of food allergens, specifically precautionary allergen labelling (PAL) e.g. ‘May be present: allergen x, allergen y…’.

1.3Procedure for assessment

This proposal is being assessed under the Major Procedure requirements of the FSANZ Act, which require two rounds of public consultation. Any draft variation of the Code will be provided for comment at the next round of public consultation. Following this, the FSANZ Board will consider a final draft variation of the Code, and if approved, this will be provided to theForum for their consideration.

1.4Risk assessment

Two risk assessment activities have been undertaken by FSANZ at this stage of Proposal P1044 to explore the issues associated with introducing PEAL. These activities are:

an assessment of safety issues relating to food allergy associated with fish, crustacea and molluscs; tree nuts; and cereals including advice from FSANZ’s Food Allergy and Intolerance Scientific Advisory Group (FAISAG)[3].
a preliminary assessment of consumer understanding, attitudes and behaviour in relation to food allergen labelling.

The details of the risk assessment activities can be found in Supporting Documents 1 and 2. The findings of the risk assessment are also summarised throughout Section 3 this report as they apply to the various issues under consideration.

2Background

2.1The current standards

2.1.1Standard 1.2.3 – Information requirements – warning statements, advisory statements and declarations

Section 1.2.3—4 of Standard 1.2.3 lists the specific foods and substances that must be declared when present in food as an ingredient or as an ingredient of a compound ingredient; a substance used as a food additive (or an ingredient or component of such a substance); or a substance or food used as a processing aid (or an ingredient or component of such a substance or food). It should be noted that although a declaration of the food or substance is required, there is no requirement about the where declarations are to be made on the label of a packaged food.

The foods and substances requiring mandatory declaration are cereals containing gluten, crustacea, egg, fish, milk, peanuts, soybeans, sesame seeds, tree nuts, lupin (noting there are specific foods exempted as outlined below) and added sulphites in amounts of 10 mg/kg or more. Lupin was added to this list on25 May 2017. Food businesses have until 26 May 2018 to meet mandatory allergen declaration requirements for any foods containing lupin.

Subsection 1.2.3—4(1) includes some exemptions to the declaration requirements, where FSANZ has assessed certain foods and ingredients as safe for allergies to wheat, soy, milk, tree nuts or fish (for example, in relation to milk, alcohol distilled from whey).

2.1.2Standard 1.2.1 – Requirements to have labels or otherwise provide information

For food not required to bear a label (e.g. food for sale displayed in an assisted service display cabinet), Standard 1.2.1 requires the declaration of the presence of allergens to either be displayed in connection with the display of the food, or provided to the purchaser upon request (subsection 1.2.1—9(6)).

2.1.3Standard 1.2.4 – statement of ingredients

Standard 1.2.4 – Information requirements – statement of ingredients sets out the requirements for how ingredients must be declared in a statement of ingredients. Ingredients must be declared by either a name by which the ingredient is commonly known, a name describing the true nature of the ingredient, or a generic name for the ingredient listed in Schedule 10.

Schedule 10 lists the generic names that can be used and includes conditions for the use of certain generic names. This provides clarification on the terminology to be used when certain generic names are used in the statement of ingredients.

The generic names and their conditions in Schedule 10, relevant to allergens, are:

‘cereals’ and ‘starch’, where the specific name of the cereal must be listed if the cereal is wheat, rye, barley, oats or spelt or a hybridised strain of one of these cereals
‘nuts’, where the specific name of the nut must be declared
‘fish’, where the specific name of a crustacea ingredient must be declared
‘fats’ or ‘oils’, where the specific source name must be declared if the source of the oil is lupin, peanut, sesame or soybean (unless the soybean oil has been degummed, neutralised, bleached or deodorised).

2.2Voluntary food industry guidelines

The Australian Food and Grocery Council (AFGC) has developed a Food Industry Guide to Allergen Management and Labelling (AFGC Guide) (AFGC 2007) to assist the food industry in making allergen declarations. This guide has also been adopted by the New Zealand Food and Grocery Council. The AFGC Guide sets out a recommended approach to allergen labelling consisting of:

declaring in bold, allergenic foods and substances and their derivatives in the statement of ingredients, and
an ‘allergen summary statement’ (referred to hereafter in this report as a ‘contains’ statement’). A ‘contains’ statement lists the allergens present in the food, and is separate to the statement of ingredients; e.g. ‘Contains: allergen x, allergen y…’. ).

The AFGC Guide provides recommended allergen labelling formats (which cover the use of bold text) for industry to adopt, , legibility, terms to beused for declaring allergens, and indicates the ‘contains’ statement should appear directly below the statement of ingredients on a separate line. The AFGC Guide also contains guidance for the display of voluntary PAL statements (noting they are out of scope for this proposal).

With respect to the terms to be used in declarations, the AFGC Guide recommends:

allergens must be declared using plain English terms consistent with the Code
the gluten source (grain source) is qualified in the statement of ingredients at all times, and the ‘contains’ statement can either include the name of each of the source grains or use the phrase ‘glutencontaining cereals’. If only one gluten-derived ingredient is declared in the statement of ingredients, then the recommendation is for the summary statement to include the specific name of the source grain.
if the product contains tree nuts, the specific name of the tree nut(s) should be declared in the statement of ingredients when added as a direct ingredient, whereas the ‘contains’ statement can use either the specific name of the tree nut or the general term ‘tree nuts’. The AFGC Guide recommends against the use of the term ‘nuts’.
if the label size or other variables do not permit the use of the recommended labelling format, then qualifying allergenic substances (except for gluten) in the statement of ingredients is optional when a ‘contains’ statement is present. However, allergenic substances should always be qualified in the statement of ingredients when a ‘contains’ statement is not present (e.g. ‘vegetable oil (soy)’ or ‘Soybean oil’).

2.3International and overseas regulations

FSANZ has considered international and overseas standards and regulations of Codex Alimentarius, the European Union, Canada and the United States of America for allergen labelling. These are:

CODEX STAN 1-1985 General Standard for the Labelling of Prepackaged Foods (Codex, 1985)
European Union Regulation 1169/2011 (Council of the European Union 2011) on the provision of food information to consumers
Canadian Food and Drug Regulations (C.R.C., c. 870) (Department of Justice, 2013)

United States Code Title 21 Food and Drugs, Chapter 9 – Federal Food, Drug and Cosmetic Act (Office of Law Revision Counsel, 2014a and 2014b), which incorporates the requirements in the Food Allergen Labelling and Consumer Protection Act 2004.

Subsequent sections and tables in this report describe how the Australian and New Zealand allergen labelling requirements compare with these international and overseas requirements.